Child-Resistant Wallet Package for Dosage Forms

ABSTRACT

The invention relates to, among other things, a wallet package for presenting blister sheets comprising: (1) a first wallet panel with a width and height (without limitation as to shape); (2) a blister sheet comprising dosage forms enclosed between a first side material and a second side material, the second side material having one or more blister barriers, wherein the blister sheet is secured to the first wallet panel such that (i) the dosage forms and the corresponding area of the blister barrier(s) can nonetheless be pulled away from the first wallet panel, or (ii) an edge of the blister sheet can be pulled sufficiently away from the first wallet panel so that blister access devices for said blister barrier(s) can be accessed; and (3) additional wallet panels with a width and height hingably connected, among themselves and the first wallet panel, such that when folded to a fold position a resulting width and height of the folded wallet package is about the width and height of a largest said wallet panel, wherein the wallet package can be reversibly folded to the fold position to cover the blister sheet, and reversibly unfolded to uncover the blister sheet.

The present invention relates to wallet packaging for dosage forms, such as dosage forms for medicaments, herbal extracts, vitamins, or the like.

Wallet packages for dosage forms have gained popularity as vehicles for delivering medicaments and the like to consumers. In these packages, blister packs in which dosage units can be pushed through a retaining barrier are adhered between layers of cardboard or the like. The dosage units can be viewed through holes in one of the sandwiching layers, with this layer typically having language that helps the user comply with dosage requirements, dosage schedule or the like. To access a dosage unit, it may be pushed through the back barrier and a corresponding hole in the other sandwiching layer. Other panels of cardboard allow the sandwiching layers to be folded into the wallet, and provide surfaces on which to provide promotional material, compliance information, safety information, or the like.

What has not been available is a cost-effective means to have the advantages of a wallet package along with child resistance. Efforts to provide such child resistance have typically involved making mechanical puzzles or other barriers involving the packaging around the blister sheet. For example, one device must be opened, a cardboard button engaged, and the working part of the wallet device slid out, as illustrated in FIG. 13. In other devices wallet packaging material must be removed, as may be facilitated with pull tabs, or pushed through. It has not been recognized that child-resistance as embodied in the blister sheet itself can be effectively incorporated into wallet designs.

SUMMARY OF THE INVENTION

In one embodiment, the invention relates to a wallet package for presenting blister sheets comprising: (1) a first wallet panel with a width and height (without limitation as to shape); (2) a blister sheet comprising dosage forms enclosed between a first side material and a second side material, the second side material having one or more blister barriers, wherein the blister sheet is secured to the first wallet panel such that (i) the dosage forms and the corresponding area of the blister barrier(s) can nonetheless be pulled away from the first wallet panel, or (ii) an edge of the blister sheet can be pulled sufficiently away from the first wallet panel so that blister access devices for said blister barrier(s) can be accessed; and (3) additional wallet panels with a width and height hingably connected, among themselves and the first wallet panel, such that when folded to a fold position a resulting width and height of the folded wallet package is about the width and height of a largest said wallet panel, wherein the wallet package can be reversibly folded to the fold position to cover the blister sheet, and reversibly unfolded to uncover the blister sheet.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1F illustrate various views of a wallet package of the invention.

FIG. 2 shows another embodiment of a wallet package of the invention.

FIGS. 3A-3C illustrate various views of a wallet package of the invention.

FIG. 4 shows another embodiment of a wallet package of the invention.

FIG. 5 shows another embodiment of a wallet package of the invention.

FIG. 6 shows another embodiment of a wallet package of the invention.

FIG. 7 shows another embodiment of a wallet package of the invention.

FIGS. 8A and 8B show another embodiment of a wallet package of the invention.

FIGS. 9-11 shows further embodiments of wallet package of the invention.

FIGS. 12 and 13 show a wallet packages.

DETAILED DESCRIPTION OF THE INVENTION

The wallet package can be arranged with blister sheets secured face down on a panel, or face up. The face down embodiments are illustrated first.

Downward-Facing Embodiments

FIG. 1 illustrates an embodiment of the invention utilizing wallet package 10 with four panels and three folds. A wide variety of fold sequences, layouts of panels, and numbers of panels can be used. Each illustrated exemplary panel has a first and second side (sides a and b, respectively). The first sides, 1 a, 2 a, 3 a and 4 a can be seen in FIG. 1A. Panel side 4 a has cutouts 11 (as exemplified, 2 rows of 4) The dotted box illustrates where blister sheet 20, exemplified in FIG. 1B, is fitted. Blister sheet 20, turned over from the orientation illustrated, is fitted corner a to corner a, corner b to corner b, and so on, such that protrusions 22 (see FIG. 1C) fit into cutouts 11.

The blister sheet has one or more backing layers of sufficient strength that a dosage unit (i) cannot be conveniently pushed through the backing layer(s) without peeling off some or all of at least one of the backing layers or (ii) can only be pushed through with a force sufficient to provide child-resistance. For example, as exemplified in the cutaway of FIG. 1C, the backing layers are made up of a vapor barrier 21B (e.g., foil), and a reinforcing layer 21C. Reinforcing layer 21C can be layered against (such as adhered to) vapor barrier 21B, and can be peeled away from outer layer 21A with or without all or part of the underlying vapor barrier 21B. As will be understood in the art, in many cases only a portion of the area of reinforcing layer 21C under a given protrusion 22 may need to be peeled to make it convenient to push dosage unit 23 through the remaining backing layer structure. Outer layer 21 may or may not be transparent.

The layers (of the backing layers) adapted to be peeled away are typically strong enough to not tear (except along perforations, cuts or other deliberate weakened structures) during the peeling process. These layers can be, for example, polymer-reinforced paper, polymer sheets, and the like.

The dual-arrowed arcs shown in FIG. 1A, show illustrative fold directions. Illustrated fold 1D shows the fold of first side 1 a, onto first side 2 a, to yield the folded view of FIG. 1D, where, as a result of the fold, second side 1 b is face up. In FIG. 1D, blister sheet 20 is shown adhered in place on first side 4 a, with its back side showing. The dark arrows illustrate positions for barrier access devices (defined below). Lines 24 can be perforations, cuts, or other weakenings in the reinforcing layer 21C, such that any given blister barrier (defined below) is isolated to one dosage unit (or designated set of dosage units if appropriate). Or, lines 24 can simply be boundaries between areas (again blister barriers) corresponding to dosage units (or sets of dosage units), and may have no physical presence on the blister sheet. Perforations can be through all layers of the blister sheet. Blister access devices, if present, can be located in any number of locations on the blister sheet. Perforations or cuts of lines 24, for example, can be deeper at the barrier access devices to facilitate manual access.

First and second reusable closures 17A and 17B allow the wallet device to be stably but releasably closed to enclose the back side of blister sheet 20.

Fold 1E yields the view of FIG. 1E, where second side 4 b can include compliance assistance printing. First and second reusable closures 12A and 12B allow the wallet package 10 to be releasably held in a closed position. Fold 1F yields the view of FIG. 1F, where second side 2 b includes printing of illustrative marketing information. The reusable closures (e.g., 12A, 12B, 17A, 17B) can be of a wide variety known in the art, including reclosable glue seals (in which case one of closures of a pair {12A or 12B, or 17A or 17B} is simply wallet material suitable for accepting the glue seal provided by the other closure), hook and loop closures such as Velcro™, snaps, buttons, tuck and fit, and the like. Closures can be tapes or straps that partially or fully wrap around the folded wallet package. For example, closures can be label closures (as known in the art) which can be reclosable and/or tamper evident.

FIG. 2 shows an illustrative wallet package 30 with cutouts 31, that uses an alternative fold pattern (from among the many available).

The various panels of a wallet package can be used to provide printing with marketing, dosage, warnings, and the like. Booklets can be securely or releasably affixed to a panel. For example, a product insert, such as one required by a regulatory agency, can be so secured or affixed. Or, secured or affixed can be a booklet that provides compliance assistance, such as a generic calendar with checkoffs, or the like.

It will be recognized that a wide variety of layouts of dosage units can be used in a blister sheet in a wallet package of the invention.

For simplicity, a number of additional embodiments shall be illustrated in a 4-panel layout similar to that of wallet package 10, with at least the first fold previously illustrated (fold 1D) already made.

FIG. 3 shows an exemplary embodiment of a wallet package 50 in which blister sheet 60 can, in part, be folded away from panel 4, for example along optional hinges 65, thereby allowing greater manual access to the barrier access devices. FIG. 3B shows the two illustrated hinges 65 being used, and FIG. 3C shows just one such hinge engaged. In the absence of hinge structure, the dosage units can still be drawn away from panel 4. Protrusions 62 are illustrated as protruding through panel 4, though this can vary with embodiments. The blister sheet can be secured to panel 4 at, for example, contact surface 66. Securing can be by a number of methods, such as adhesive methods, stitching, stapling, riveting, or the like. Optional closure-facilitating area 5 illustrates extra spine material used to facilitate one illustrative pattern for folding the panels. If panel 4 b provides compliance assistance printing, then the presence or absence of dosage units aligned with the compliance information can be apparent by looking through the cutouts.

By pulling the dosage units away from panel 4, the child-resistant opening mechanism can be more readily accessed. For example, blister access devices (defined below) located along an outer edge (pulled away from panel 4) can be accessed and engaged more easily. If a scissors or the like are needed to initiate a tear, pulling away allows access for a cut, and for any subsequent tear. Or, perforations can allow individual dosage units (or sets of dosage units) to be torn off, as facilitated by pulling away form panel 4, and then the child-resistant opening mechanism can be operated.

FIG. 4 shows one of many other folding sequences or patterns for wallet package 70, which is otherwise analogous to wallet package 50 (with folds 85 and protrusions 82). Fold A, in this exemplification, is conducted before fold B.

Hinges, such as hinges 65 or 85, can be, for example, fold lines, where folding can be facilitated by methods known in the art, such as perforation along the fold line, compression along the fold line, heat with compression, pre-folding, or the like. The hinges can be designed to bias, to some extent, the blister pack tending to return to a flat aspect (ignoring the protrusions), so as to facilitate closing the wallet package.

FIG. 5 shows a wallet package 90 in which the contact surface 106 is to one side of the blister sheet, and optional hinge 105 is on the same side. The contact surface can be on any side, such that the can pulled up from the right (as here), left, top or bottom (or still other orientations depending upon the blister sheet geometry, and the like). The hinge can be formed for example by wallet panel material, such as folds in the wallet panel. For example, supposing that contact surface 106 is on the left, top or bottom, a portion of wallet panel can extend to the corresponding left, top or bottom, connected by a hinge (such as a crease). The extended portion can fold over, and be adhered to, the contact surface, in which case the blister sheet 100 need not be hinged—while preserving all the function of wallet package 90 (or similar designs such as wallet package 230).

Lines 104A and 104B are typically to the other side from the contact surface (here, on the right side). Italicized numbers 1 through 8 illustrate an optional order of usage for the dosage units. After dosage units 1-4 have been used, in some embodiments line 104B allows the used portion of the blister sheet to be torn away, to provide greater access to the barrier access devices for dosage units 5-8. It will be recognized that the same multiple rows, and tearing away used rows, can be used with butterfly designs such as found in FIG. 3.

Shaded areas 108A, 108B, 108C, 108D, are optional areas under the blister sheet that are secured to panel 4 with reclosable glue seals.

FIG. 6 illustrates that nonlinear design elements can be incorporated into the presentation of dosage forms (wallet package 110, hinges 125, lines 124, protrusions 122).

FIG. 7 illustrates wallet package 130, with lines 144. The blister sheet 140 can be secured over various areas, such as contact surface 146A, contact surface 146B, or contact surface 146C. Even if the secured area is relatively close to the barrier access devices, some separation allows more room for a users' fingers to manipulate the barrier access devices, with less interference from panel 4.

Upward-Facing Embodiments

Similar embodiments to those described above, but with the dosage units oriented upwards, are shown in FIGS. 8A, 8B, 9, 10 and 11. In FIG. 8A and 8B, wallet package 210 has blister sheet 220, optional hinge 225, contact surface 226, protrusions 222 and lines 224. In FIG. 9, wallet package 230 has blister sheet 240, optional hinge 245, contact surface 246, and optional reclosable glue seals 248A, 248B. FIG. 10 illustrates wallet package 250. The blister sheet 260 can be secured over various areas, such as contact surface 266A, contact surface 266B, or contact surface 266C. In FIG. 11, wallet package 270 is folded in one of the many alternative fold patterns.

FIG. 12 illustrates a prior art design in which a blister sheet is adhered between panel 3 and panel 4, such that there is no access to the back side of the blister sheet.

Definitions

The following terms shall have, for the purposes of this application, the respective meanings set forth below.

Dosage Form

The term “dosage form” includes any solid form that is sufficiently self-cohesive to be presented in a blister sheet, and includes an amount of a material for delivery to a subject (such as by ingestion, as a suppository, as a lozenge, as a mucosal adherent, or the like).

Blister Barrier

A “blister barrier” is a covering for one or more dosage units of which at least a portion must be peeled, torn, cut, or pushed through to allow a user of a dosage unit to conveniently, but in a child-resistant manner, access the dosage unit. Any blister barrier usable to provide child resistance in a blister sheet can be used in the invention. Child resistance is as recognized in the pharmaceutical industry (e.g., F1, F2, F3 levels of child resistance).

Blister Access Device

A “blister access device” is any device used in a child-resistant blister sheet. Blister access devices can include, for example, a pull tab, a pull tab access by tearing perforations to allow peeling to reveal the pull tab, notches to facilitate tearing, and the like.

Wallet Panels

A “wallet panel” is any panel made of a moderately stiff material allowing a wallet package to be reusably opened and closed over a useful lifetime. It will be recognized that, depending on dimension, the support provided by adhered components, and the like, that the stiffness required for making a useful wallet package can vary.

Subject

A “subject” is any animal, including a human, for which it may be appropriate to delivery a dosage form.

Publications and references, including but not limited to patents and patent applications, cited in this specification are herein incorporated by reference in their entirety in the entire portion cited as if each individual publication or reference were specifically and individually indicated to be incorporated by reference herein as being fully set forth. Any patent application to which this application claims priority is also incorporated by reference herein in the manner described above for publications and references.

While this invention has been described with an emphasis upon preferred embodiments, it will be obvious to those of ordinary skill in the art that variations in the preferred devices and methods may be used and that it is intended that the invention may be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications encompassed within the spirit and scope of the invention as defined by the claims that follow. 

1. A wallet package for presenting blister sheets comprising: a first wallet panel with a width and height; a blister sheet comprising dosage forms enclosed between a first side material and a second side material, the second side material having one or more blister barriers, wherein the blister sheet is secured to the first wallet panel such that (i) the dosage forms and the corresponding area of the blister barrier(s) can nonetheless be pulled away from the first wallet panel, or (ii) an edge of the blister sheet can be pulled sufficiently away from the first wallet panel so that blister access devices for said blister barrier(s) can be accessed; and additional wallet panels with a width and height hingably connected, among themselves and the first wallet panel, such that when folded to a fold position a resulting width and height of the folded wallet package is about the width and height of a largest said wallet panel, wherein the wallet package can be reversibly folded to the fold position to cover the blister sheet, and reversibly unfolded to uncover the blister sheet.
 2. The wallet package of claim 1, wherein one portion of the blister sheet is secured to the first wallet panel, and a second portion comprises barrier access device(s) and is not secured to the first wallet panel.
 3. The wallet package of claim 2, wherein the first portion is close to, but separate from, the barrier access device(s), the separation facilitating a user's fingers to engage the barrier access devices
 4. The wallet package of claim 2, wherein the blister sheet has a third portion comprising barrier access device(s) and is not secured to the first wallet panel, wherein the second and third portions are separated by the first portion.
 5. The wallet package of claim 1, wherein one portion of the blister sheet is secured to the first wallet panel, and a second portion comprises dosage forms and barrier access device(s) and is not secured to the first wallet panel.
 6. The wallet package of claim 5, wherein the first and second portions of the blister sheet are hingably connected.
 7. The wallet package of claim 6, comprising perforations or other tear-facilitations so that portions of the blister sheet corresponding to the blister barrier(s) can be serially removed.
 8. The wallet package of claim 5, comprising perforations or other tear-facilitations so that portions of the blister sheet corresponding to the blister barrier(s) can be serially removed.
 9. The wallet package of claim 5, wherein the blister sheet has a third portion comprising dosage forms and barrier access device(s), and is not secured to the first wallet panel, wherein the second and third portions are separated by the first portion.
 10. The wallet package of claim 9, wherein the first and second portions of the blister sheet, and the first and third portions of the blister sheet, are hingably connected.
 11. The wallet package of claim 10, comprising perforations or other tear-facilitations so that portions of the blister sheet corresponding to the blister barrier(s) can be serially removed.
 12. The wallet package of claim 9, comprising perforations or other tear-facilitations so that portions of the blister sheet corresponding to the blister barrier(s) can be serially removed. 